Tag Archives: AHPA

Webinar: FDA Inspections & Emerging cGMP Compliance Issues for Dietary Supplements

The American Herbal Products Association (AHPA) will present a two-hour educational webinar titled “FDA Inspections & Emerging cGMP Compliance Issues for Dietary Supplements – Recent 483s,” on Thursday, October 1, 2015, from 1:00-3:00p.m. ET.
A regularly occurring event and part of the association’s cGMP Compliance Series, this two-hour, webinar is designed to help those businesses in the dietary supplement industry understand the elements of 21 CFR 111/current Good Manufacturing Practices (cGMP) regulations that are most focused on during recent FDA inspections. This knowledge will assist business with better allocating their compliance resources.
Veteran industry legal experts will provide attendees with an insider’s view of current cGMP enforcement landscape. AHPA staff will offer a detailed analysis of the association’s repository of inspection data, widely regarded as the most in-depth in the industry and which includes actual FDA 483 Inspection reports, Observation forms, and establishment inspection reports (EIRs).
Topics:
  • What aspects of the cGMP are you responsible for during an inspection?
  • FDA “Hot buttons” during inspections and what can be done to prepare as well as mitigate
  • Detailed analysis of recent (2014-present) FDA inspection reports
  • What the inspection reports teach and how to appropriately respond to a Form FDA 483
  • Answers to your questions during the Q&A session
Presenters:
  • Tony Young, Kleinfeld, Kaplan & Becker/AHPA General Counsel
  • Marian Boardley, Marian Boardley Consulting, LLC
  • Merle Zimmermann, Ph.D., AHPA
Moderator:
  • Jane Wilson, AHPA
A 20-30 minute Q&A session will follow the speaker’s presentations to allow attendees to anonymously ask specific questions about FDA inspections, enforcement actions, and related matters.